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Sildenafil

SILDORA

Regulatory Class: Rx
Generic Name: Sildenafil Citrate
Formulation/s: Film-coated tablet contains 50 mg of Sildenafil (as citrate)

Indications or Use: Management of erectile dysfunction.

Dosage and Directions for Use: Adult 50 mg approximately 1 hour before sexual activity. May be increased to 100 mg or decreased to 25 mg. Maximum: 100 mg once daily.

Administration: Take with or without meals.

Contraindication: Hypersensitivity. Not indicated for use in women. Co-administration w/ nitric oxide donors or nitrates.

Special Precaution: Men inadvisable to sexual activity due to underlying cardiovascular diseases, Myocardial infarction & stroke or life-threatening arrhythmia w/in the last month; resting hypotension (BP <90/50) or hypertension (BP >170/110); cardiac failure causing unstable angina; retinitis pigmentosa. Hepatic & severe renal impairment; patients w/ anatomical penis deformation or hematologic disorders predisposing to priapism. Patients who experience dizziness or visual disturbances should not drive or operate machinery.

Adverse Reaction: Serious cardiovascular events including Myocardial infarction, sudden cardiac death, ventricular arrhythmia; headache, flushing, dizziness, hypotension, angina pectoris, face edema, photosensitivity reaction, shock, dyspepsia, vomiting, dry mouth, arthritis, neuropathy, depression, insomnia, nasal congestion & asthma.

Interactions: Increased plasma conc. w/ cimetidine. Reduced clearance w/ CYP3A4 inhibitors (e.g., cimetidine, itraconazole, ketoconazole, erythromycin). Potentiates hypotensive effect of nitrates.

Presentation/ Packaging: Film-coated tablet 50 mg x 4’s.

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